Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07018661

[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

Led by Leiden University Medical Center · Updated on 2025-08-27

250

Participants Needed

10

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if a new type of scan, FAPI-PET/CT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases. The main questions it aims to answer are: * In how many patients can FAPI-PET/CT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)? * In how many patients does FAPI-PET/CT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed? Apart from the usual care gastric cancer patients receive, participants will: * Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time) * Complete a number of questionnaires, which will take approximately 4 hours in total

CONDITIONS

Official Title

[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy
  • Age greater than or equal to 18 years
  • Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen
  • Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making
  • Patients must have given written informed consent
  • Patients who have recently participated in an interventional study with an investigational medicinal product may only participate if an interaction with study procedures is deemed unlikely by the study team
Not Eligible

You will not qualify if you...

  • Siewert type I-II esophagogastric junction tumor
  • Unfit or unwilling to undergo study procedures
  • Unfit or unwilling to undergo surgery
  • Pregnancy at time of the [18F]AlF-FAPI-74 PET/CT scan
  • Incapacitated subjects without decision-making capacity
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Illiterate patients unable to complete the resource use and quality of life questionnaires
  • Inability to undergo PET/CT scans due to claustrophobia, weight limits, or inability to lie flat for approximately 30 minutes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

ZGT

Almelo, Netherlands

Not Yet Recruiting

2

Amsterdam UMC

Amsterdam, Netherlands

Not Yet Recruiting

3

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

Not Yet Recruiting

4

Rijnstate

Arnhem, Netherlands

Not Yet Recruiting

5

Catharina Ziekenhuis

Eindhoven, Netherlands

Not Yet Recruiting

6

Zuyderland

Geleen, Netherlands

Not Yet Recruiting

7

UMC Groningen

Groningen, Netherlands

Not Yet Recruiting

8

Leids Universitair Medisch Centrum

Leiden, Netherlands

Actively Recruiting

9

Erasmus MC

Rotterdam, Netherlands

Not Yet Recruiting

10

UMC Utrecht

Utrecht, Netherlands

Not Yet Recruiting

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Research Team

S

Sarah Spruijt, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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